ACETYLCYSTEINE

N/A

Manufactured by Cumberland Pharmaceuticals Inc.

18,714 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ACETYLCYSTEINE

ACETYLCYSTEINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cumberland Pharmaceuticals Inc.. The most commonly reported adverse reactions for ACETYLCYSTEINE include DYSPNOEA, DRUG INEFFECTIVE, OFF LABEL USE, PNEUMONIA, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETYLCYSTEINE.

Top Adverse Reactions

DYSPNOEA740 reports
DRUG INEFFECTIVE633 reports
OFF LABEL USE629 reports
PNEUMONIA589 reports
PYREXIA485 reports
FATIGUE418 reports
NAUSEA415 reports
DIARRHOEA327 reports
HYPERTENSION308 reports
VOMITING308 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE304 reports
DEATH298 reports
COUGH292 reports
HYPOTENSION282 reports
CONDITION AGGRAVATED272 reports
DRUG INTERACTION257 reports
ASTHMA256 reports
HEADACHE249 reports
PAIN239 reports
TOXICITY TO VARIOUS AGENTS237 reports
ANAEMIA236 reports
PRURITUS235 reports
DIZZINESS230 reports
ACUTE KIDNEY INJURY228 reports
PRODUCTIVE COUGH226 reports
ASTHENIA222 reports
RASH217 reports
RESPIRATORY FAILURE217 reports
SEPSIS207 reports
GENERAL PHYSICAL HEALTH DETERIORATION201 reports
MALAISE197 reports
DECREASED APPETITE187 reports
WHEEZING187 reports
OVERDOSE175 reports
FALL173 reports
TACHYCARDIA171 reports
THROMBOCYTOPENIA168 reports
CONSTIPATION159 reports
OEDEMA PERIPHERAL159 reports
DYSPNOEA EXERTIONAL158 reports
INSOMNIA157 reports
BRONCHIECTASIS156 reports
RENAL FAILURE155 reports
ABDOMINAL PAIN154 reports
WEIGHT DECREASED154 reports
TOXIC EPIDERMAL NECROLYSIS147 reports
BACK PAIN146 reports
COVID 19145 reports
ANXIETY138 reports
ARTHRALGIA138 reports
BREATH SOUNDS ABNORMAL138 reports
TRANSIENT ISCHAEMIC ATTACK138 reports
HYPOKALAEMIA137 reports
ATRIAL FIBRILLATION136 reports
BLOOD CREATININE INCREASED136 reports
FULL BLOOD COUNT ABNORMAL136 reports
INFECTION135 reports
GASTROOESOPHAGEAL REFLUX DISEASE134 reports
URINARY TRACT INFECTION133 reports
STEVENS JOHNSON SYNDROME132 reports
WEIGHT INCREASED130 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE129 reports
BENIGN PROSTATIC HYPERPLASIA128 reports
ERYTHEMA128 reports
ALANINE AMINOTRANSFERASE INCREASED126 reports
SOMNOLENCE123 reports
CORONARY ARTERY DISEASE122 reports
OBSTRUCTIVE AIRWAYS DISORDER122 reports
SEPTIC SHOCK122 reports
PRODUCT USE IN UNAPPROVED INDICATION121 reports
CONGENITAL HIATUS HERNIA120 reports
FEBRILE NEUTROPENIA120 reports
ASPARTATE AMINOTRANSFERASE INCREASED119 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION119 reports
RENAL IMPAIRMENT113 reports
TREMOR111 reports
CARDIAC FAILURE110 reports
HYPERHIDROSIS109 reports
CARDIAC ARREST108 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES108 reports
HYPERSENSITIVITY107 reports
NEUTROPENIA107 reports
CHEST PAIN106 reports
LOSS OF CONSCIOUSNESS105 reports
PAIN IN EXTREMITY105 reports
PLATELET COUNT DECREASED105 reports
PLEURAL EFFUSION105 reports
METABOLIC ACIDOSIS102 reports
NASOPHARYNGITIS102 reports
JOINT INJURY100 reports
MICTURITION URGENCY100 reports
HYPERCHOLESTEROLAEMIA99 reports
CHEST DISCOMFORT98 reports
DEPRESSION97 reports
HYPONATRAEMIA93 reports
HYPOXIA93 reports
BRONCHITIS92 reports
OXYGEN SATURATION DECREASED92 reports
LUNG DISORDER91 reports
MYALGIA91 reports

Report Outcomes

Out of 8,851 classified reports for ACETYLCYSTEINE:

Serious 89.8%Non-Serious 10.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,141 (50.7%)
Male4,013 (49.2%)
Unknown9 (0.1%)

Reports by Age

Age 80218 reports
Age 72192 reports
Age 69183 reports
Age 62171 reports
Age 70171 reports
Age 75170 reports
Age 61166 reports
Age 64164 reports
Age 79152 reports
Age 74148 reports
Age 65147 reports
Age 73147 reports
Age 76139 reports
Age 63138 reports
Age 67135 reports
Age 77134 reports
Age 59130 reports
Age 66128 reports
Age 58122 reports
Age 60121 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ACETYLCYSTEINE?

This profile reflects 18,714 FDA FAERS reports that mention ACETYLCYSTEINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETYLCYSTEINE?

Frequently reported terms in FAERS include DYSPNOEA, DRUG INEFFECTIVE, OFF LABEL USE, PNEUMONIA, PYREXIA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETYLCYSTEINE?

Labeling and FAERS entries often list Cumberland Pharmaceuticals Inc. in connection with ACETYLCYSTEINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.